Installation Qualification Protocol for Sterility Test Isolator
Document Control:
- Document Number: IQ-STI-001
- Version: 1.0
- Effective Date: [Insert Date]
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]
Objective:
The objective of this Installation Qualification (IQ) protocol is to verify that the Sterility Test Isolator/System is installed according to the manufacturer’s specifications and is functioning as intended to support sterility testing in the NDDS process.
Scope:
This protocol applies to the Sterility Test Isolator/System used in the microbiology area for conducting sterility testing of NDDS products. It ensures compliance with regulatory requirements and internal standards.
Responsibilities:
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is maintained and calibrated.
Prerequisites:
- All installation procedures must be completed.
- Training records for personnel involved in the validation process must be available.
- All necessary utilities (water, electricity, etc.) must be verified and operational.
Equipment Description:
The Sterility Test Isolator/System is designed for conducting sterility tests in a controlled environment. It features advanced technology to ensure sterility and reliability, including leak integrity airflow monitoring and VHP cycle capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Leak Integrity Test | No leaks detected | Test report |
| IQ-02 | Airflow Verification | Airflow within specified range | Calibration certificate |
| IQ-03 | VHP Cycle Audit Trail Review | All cycles completed successfully | Audit trail report |
Detailed Test Cases:
- Test Case IQ-01: Conduct a leak integrity test using a calibrated leak detector. Document any findings.
- Test Case IQ-02: Measure and record airflow at designated points in the isolator. Ensure readings fall within specified limits.
- Test Case IQ-03: Review the VHP cycle audit trail to confirm that all cycles have been executed according to the protocol.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be initiated if necessary.
Approvals:
All results must be reviewed and approved by the Quality Assurance department before the equipment is released for use.
Data Integrity Checks:
- Ensure all electronic data is backed up and securely stored.
- Verify that all data entries are time-stamped and user-identified.
- Conduct periodic audits of the data management system to ensure compliance.